CL-4
SEP 16
New Jersey Department of Health
Clinical Laboratory Improvement Services
PO Box 361
Trenton, NJ 08625-0361
APPLICATION FOR
CLINICAL LABORATORY LICENSE
(CLIA WAIVED TESTS ONLY)
FOR STATE USE ONLY
Calendar Year
Initial ($200 Fee)
Renewal ($200 Fee)
Date Received Received By Check/E-Pmt. Rec’d Approved By
LABORATORY INFORMATION
Name of Laboratory
NJ CLIS ID Number (7 digit number)
Laboratory Address (Street Address/PO Box)
CLIA Number
(City, State, Zip Code)
Mailing Address [where License(s) should be mailed]
(City, State, Zip Code)
Laboratory Telephone Number
Laboratory Fax Number
Facility Type (Select one)
Physician Office Laboratory
School
City
County
Home Health Agency
Pharmacy Associated Clinic
Health Screening (incl. Mobile)
Other: ____________
Name of Contact Person
Contact Telephone No.
Contact Email Address
Normal Hours of Laboratory Operation (indicate specific hours EACH day):
Monday:
Tuesday:
Wednesday:
Thursday:
Friday:
Saturday:
Sunday:
LABORATORY DIRECTOR INFORMATION
Name of Laboratory Director
State Medical License Number
Laboratory Director’s Degree
Telephone No.
Email Address
Laboratory Director’s Time on Premises
Monday:
Tuesday:
Wednesday:
Thursday:
Friday:
Saturday:
Sunday:
PRIMARY GENERAL SUPERVISOR INFORMATION
Name of Primary General Supervisor
Primary General Supervisor’s Degree
Telephone No.
Email Address
Primary General Supervisor’s Time on Premises
Monday:
Tuesday:
Wednesday:
Thursday:
Friday:
Saturday:
Sunday:
OWNERSHIP INFORMATION
Name of Owner/Authorized Agent
EIN Federal Tax ID
Address (Street Address/PO Box, City, State, Zip Code)
Telephone Number
Type of Entity (Select one)
Individual Partnership Corporation Non-Profit
Government Entity (Select one)
State County Municipal
APPLICATION FOR CLINICAL LABORATORY LICENSE - (CLIA WAIVED TESTS ONLY)
(Continued)
CL-4
SEP 16
Name of Laboratory
NJ CLIS ID Number (7 digit number)
LIST OF CLIA WAIVED TESTS AND NJ STATE WAIVED TESTS PERFORMED
Select [ ] or Add CLIA-Waived (including NJ
State-Waived) Instrument or Test Kit
Name of Instrument
or Kit Manufacturer
Number of Tests
Performed Annually
Adenovirus
Chemistry Panel
ESR (Non-Automated)
Fecal Occult Blood
Hemoglobin
Hemoglobin AIC
Lipid Panel
MMP-9
Prothrombin Time (PT) and/or INR
Rapid Flu
Rapid Group A Strep
Rapid HCV
Rapid HIV
Rapid Mono
Rapid RSV
Tear Osmolarity
Urine Dipstick (Non-Automated)
Urine Drug Screening Test Cup
Urine Pregnancy
Urine Reagent Strip (Automated)
Whole Blood Glucose
Whole Blood Lead
ADDITIONAL TESTS
Total Annual Test Volume:
PROFICIENCY TESTING PROVIDER(S)
Name of Proficiency Testing Provider(s)
ATTESTATION
I, the undersigned, certify that all the information given on this application and on the accompanying attachments is true, correct, and complete
as of this date and that notification, by certified mail, of any change(s) will be made with 14 days of such change(s). I further certify that testing
will not be performed until all applicable State and Federal certificates, licenses, and required approvals have been obtained in accordance with
N.J.S.A. 45:9-42.26 et seq., N.J.A.C. 8:44-2.1 et seq., and 42 CFR 493.1 et seq.
I attest that
I have I have not been indicted for or convicted of a felony crime and that the owner(s) and laboratory director are not
presently suspended or had a CLIA certificate revoked and are not subject to pending administrative sanctions under any Federal, State or local
laws. (Attach complete documentation regarding conviction, suspension, revocation or administrative actions.
Name of Laboratory Director (Print) Signature of Laboratory Director
Date
Name of Owner (Print) Signature of Owner
Date
